An Equal Opportunity Provider and Employer 

CENTER FOR VETERINARY BIOLOGICS NOTICE 17-10

TO: Veterinary Services Leadership Team 

 Directors, Center for Veterinary Biologics 

 Biologics Licensees, Permittees, and Applicants 

FROM: Byron E. Rippke 

 Director 

SUBJECT: Discontinued Availability of Diagnostic Test Kit Serial Release Panels 

 Obtained from the Center for Veterinary Biologics (CVB) 

I. PURPOSE 

The purpose of the document is to notify veterinary biologics manufacturers that the 

CVB distribution of Serial Release Panels for the following diagnostic test kits will 

be discontinued: 

 Anaplasma Antibody Test Kit 

 Bluetongue Virus Antibody Test Kit 

 Bovine Leukemia Virus Antibody Test Kit 

 Caprine Arthritis-Encephalitis-Ovine Progressive Pneumonia (CAE-OPP) 

Virus Antibody Test Kit 

 Equine Infectious Anemia Virus Antibody Test Kit 

 Porcine Reproductive and Respiratory Syndrome Virus Antibody Test Kit 

 Pseudorabies Virus Antibody Test Kit (including gB and gI) 

The Poultry Antibody Specificity Panel utilized in development and quality control of 

some avian products will also be discontinued by the CVB. 

 

II. BACKGROUND 

For the purpose of this Notice, a Serial Release Panel refers to a collection of 

samples used to assess a diagnostic test kit. 

The CVB laboratory has routinely provided Serial Release Panels to veterinary 

biologics manufacturers. Due to reduced resources, the CVB is discontinuing these 

reagents. All Serial Release Panels above, except for the CAE-OPP and Poultry 

Antibody Specificity Panel, are available for a fee from the National Veterinary 

Services Laboratories (NVSL) as proficiency test panels (check tests). See NVSL’s 

Proficiency Test Panel web page for details. 

 Animal and Plant 

 Health Inspection 

 Service 

 Veterinary Services 

 Center for Veterinary 

 Biologics 

 1920 Dayton Avenue 

 PO Box 844 

 Ames, IA 50010 

 (515) 337-6100 
CENTER FOR VETERINARY BIOLOGICS NOTICE 17-10 

Page 2 

An Equal Opportunity Provider and Employer 

III. ACTION 

The Outline of Production, Section V.C, must include information regarding the specific 

panel or samples used for serial release testing. Firms may use an NVSL panel without 

additional justification. If a firm does not use an NVSL panel, lot/serial numbers for the 

samples must be included in the Outline of Production. These samples must be well 

characterized. This information must be approved by CVB-PEL prior to use. 

Firms may use the appropriate panel, past or present, produced by the NVSL for serial 

release testing. The most current panel supplied by the NVSL is not required. The APHIS 

Form 2008 should specify the NVSL panel used to test an individual serial, including the 

year of panel release. For a Serial to be satisfactory, all samples within a panel must be 

identified correctly. The NVSL panel used by the CVB for prelicense and routine 

confirmatory testing may not match the panel listed on the APHIS Form 2008. 

Individual control and panel member results should be reported on the APHIS Form 2008 

to be evaluated by CVB-Inspection and Compliance. 

IV. IMPLEMENTATION/APPLICABILITY 

This change is effective immediately. Necessary Outline of Production changes should 

be completed prior to releasing a serial tested by a new Serial Release Panel, or by the 

next annual review, whichever comes first.